SAN CARLOS, CA - May 13, 2009 Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has dosed its first patient in a Phase 1 IND trial of CLT-008 for hematological malignancies. CLT-008 is an off-the-shelf cell-based biologic designed to rapidly produce mature neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation, or being treated for chemotherapy- or radiation-induced neutropenia among other applications.
The Phase 1 study is an open-label, dose-escalation trial and will investigate the safety and tolerability of CLT-008 in 20 to 25 patients undergoing cord blood transplants. Dr. John Wagner, Professor of Pediatrics and Director of the Division of Hematology-Oncology and Blood and Marrow Transplantation at the University of Minnesota is the Principal Investigator for the study. Dr. Wagner is recognized internationally as an expert in the field of stem cells and use of unrelated cord blood hematopoietic stem cells in transplant settings. The trial is being conducted at the University of Minnesota.
"I am very excited to be part of this clinical study." said Dr. John Wagner. "Cord blood has become the principal source of blood forming stem cells in children and is increasingly becoming a main source of allogeneic cells for stem cell transplantation in adults with leukemia and lymphoma. However, delayed engraftment and prolonged hospitalization have been the limiting factors to its effectiveness. CLT-008, a source of blood forming progenitor cells has the potential of overcoming these obstacles, making cord blood transplants safer and more available for everyone regardless of age, size, or ethnic and racial background. CLT-008 has tremendous potential as an off-the-shelf product for patients with transient bone marrow failure whether after chemotherapy or accidental exposure to radiation."
"The initiation of this trial represents an important milestone for Cellerant," said Dr. Ram Mandalam, President and CEO of Cellerant Therapeutics. "In preclinical testing CLT-008 was shown to provide hematopoetic support to enable long-term engraftment of blood-forming stem cells, which could lead to broader use of cord blood transplants as an effective therapy for multiple life-threatening blood diseases. CLT-008 addresses a number of unmet medical needs with significant markets and we are excited to further the clinical development of CLT-008 for other indications including neutropenia in the near future."
CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In pre-clinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficiency. Cellerant is developing CLT-008 as an effective treatment for chemotherapy induced neutropenia, protection from exposure to acute radiation and facilitating cord blood transplantation.
Cellerant Therapeutics is a product-focused biotechnology company with a portfolio of advanced and development stage preclinical compounds based on the regulation of the hematopoietic (blood-forming) system. Cellerant focuses on human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerant is developing a novel, cell-based medicine (Myeloid Progenitors) as a treatment for chemotherapy- and radiation-induced neutropenia (CLT-008) as well as for Acute Radiation Syndrome. The antibody program is focused on identifying novel drug targets, and therapeutic antibodies and small molecules aimed at cancer stem cells. For more information on Cellerant, please visit http://www.cellerant.com.
For more information on Cellerant, please contact:
Cellerant Therapeutics, Inc.